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Eyestem Research secures $10 million funding to advance innovative retinal therapies, aiming for global expansion and promising trial results.

Eyestem closes $10 million (USD) funding round

4D Molecular Therapeutics advances 4D-150 for wet AMD and DME, revealing promising trial results and regulatory progress for potential market approval.

What is the status of the clinical trials 4D-150 for both DME and AMD?

A complex case of uveitis linked to syphilis highlights the need for thorough history-taking and multidisciplinary management in diagnosis and treatment.

Diagnosing neurosyphilis in a patient with a non-classic presentation

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Ophthalmology Times – Clinical Insights for Eye Specialists

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Clinical

Glaucoma

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Thomas Brunner, president & CEO, Glaucoma Research Foundation, San Francisco, CA, shares his thoughts on how living through a pandemic has influenced and altered his perspective on life — both personally and professionally — for the better.

Reflecting on life during a pandemnic


Peter J. Polack, MD, FACS, and Zora Harrison, COO at Ocala Eye in North Central Florida, share the protocols and technology their practice implemented throughout the pandemic that has enabled them to safely and efficiently treat their patients.

COVID-19: Year in the life of ophthalmology practice

Find out how one eye care practice has found success in adapting their services to ensure staff/patient safety throughout the pandemic. 

Adjusting ophthalmology practice to a pandemic 


Mary Elizabeth Hartnett, MD, FACS, FARVO,

 a distinguished professor in Ophthalmology and Visual Sciences, University of Utah, as well as director of Pediatric Retina at the John A. Moran Eye Center, and 

 a vitreous and retinal surgeon at the Wilmer Eye Institute, Johns Hopkins University, analyze two areas of 

relevant to today's field:

Dr. Hartnett highlights current research being conducted on the pathophysiology of AMD involving very long chain polyunsaturated fatty acids and new mechanism for fibrosis and neovascular AMD. 

Dr. Breazzano discusses how the COVID-19 pandemic has altered how ophthalmologists treat wet AMD, and how physicians can maximize their patient outcomes. 

Mary Elizabeth Hartnett, MD, FACS, FARVO, and Mark Breazzano, MD, discuss current research being conducted involving AMD and maximizing patient outcomes amid the pandemic. 

Analyzing AMD in research, COVID-19-era practice

Ophthalmologist Holocaust survivor shares his story

A story of survival, as told by one ophthalmologist

In this latest EyePod episode, John H. Merey, MD, possibly one of the last Holocaust survivors still in the practice of ophthalmology, shares his experience. 

EyePod: Ophthalmologist shares Holocaust survival story


Anne L. Coleman, MD, PhD, president of the American Academy of Ophthalmology (AAO), offers a preview of what attendees can look forward to from the academy's 2020 virtual annual meeting — kicking off Nov. 13-15 —including: in-depth information and innovations, free entry to the 17th annual Orbital Gala, open access to all 8 subspecialty days, new innovations, a first-ever talent show, extended access to content, and much more.


Read more about what to expect from AAO 2020


American Academy of Ophthalmology (AAO) President Anne L. Coleman, MD, PhD, offers a preview of what attendees can look forward to from the academy's virtual annual meeting — kicking off Nov. 13-15. 

What to expect from virtual AAO 2020


John J. Grande, CFP, and John S. Grande, CFP, of Grande Financial Services, discuss how having a solid financial plan in place can ease anxiety amid the ongoing coronavirus pandemic and ahead of a potential second wave, advice to ophthalmologists contemplating retirement, as well as the financial repercussions the economy may face heading into 2021.


John J. Grande, CFP, and John S. Grande, CFP, discuss why ophthalmologists should be focusing on having a financial plan ahead of a second wave in the ongoing pandemic.  

Planning for financial safety in uncertain times


Ranya Habash, MD, medical director, Technology Innovation, Bascom Palmer Eye Institute, University of Miami, speaks with 

 Sheryl Stevenson on the capabilities of telemedicine available to ophthalmologists, the impact of the pandemic in regards to FDA regulations and how it’s helped to pave the way forward / expand telemedicine, as well as why the future of telemedicine requires a new way of thinking.


Ranya Habash, MD, discusses telemedicine in ophthalmology amid the ongoing pandemic.

Spotlighting telemedicine in the year of a pandemic

S.K. Steven Houston III, MD, speaks with 

' Sheryl Stevenson on how his practice has put to use recent retina innovations and adapted to accommodate the ever-changing operating room spacing and set-up in the current 

Watch Dr. Houston's interview from the virtual 2020 ASRS meeting on how his retina practice has utilized the NGENUITY 1.4 upgrade from Alcon


S.K. Steven Houston III, MD, shares how his practice has put to use recent retina innovations and adapted to accommodate the ever-changing operating room spacing and set-up in the current COVID-19 environment.

Putting to practice retina innovations amid a pandemic

Recent study data reveal a significant rise in childhood astigmatism linked to the COVID-19 pandemic, independent of myopia.

Astigmatism in Hong Kong children increased substantially following COVID-19–era restrictions

The study findings indicated that lifestyle changes associated with the COVID-19 pandemic were connected to an increase in childhood astigmatisms.

Researchers find significant increase in childhood astigmatism post-COVID

A retrospective study showed that the gender of the ophthalmologist influenced the amount of communication with the patient, and that the pandemic had an impact. 

How COVID-19 shifted ophthalmologist-patient communication

A total of 43 patients who recovered from the SARS-CoV-2 infection with mild pneumonia were included along with 45 healthy individuals.

Choroidal vascularity index offers insight into eye health after COVID-19 recovery

The pandemic caused an overall decrease in the rates of the 10 most common ophthalmic procedures performed in 2020 when compared to the year prior.

Study finds COVID-19 led to significant decline in common eye surgeries

Editor's note - This transcript has been edited for clarity:

Glaucoma 360 is one of my favorite meetings and my presentation tomorrow, actually, talks about 10 lessons learned after the pandemic. I know many of us take care of glaucoma patients, and the COVID pandemic actually gave us insight into things that we need to do differently as we take care of patients. 

So my talk is going to be based off of 10 things that I think you walked away from that experience with. Things that happened during that period—whether it was things that were in the pipeline that seems to be accelerated because of the pandemic, or new insights we have as to taking care of our patients and deficits that there are in care. It's gonna be an exciting talk. 

I think the New Horizon Forum today focuses on some of the things that I will address in that talk. And it's just exciting to see that as a glaucoma community, we not only are seeing the issues that we face as we take care of patients, but also trying to find adequate solutions for them.

Oluwatosin U. Smith, MD, provides some key takeaways from her Glaucoma 360 2023 presentation, "Glaucoma Management Lessons Learned from a Pandemic."



Glaucoma 360: Glaucoma management lessons learned from a pandemic

Mike Watson, vice president of OraNet at Ora inc., discusses the challenges facing clinical sites in 2022 and key considerations to ensure study success. Development partners like Ora with site communities like OraNet that supplement coordinator staff, optimize patient capacity, and streamline protocols are a necessity in today’s over-burdened resource-lean clinics.

Mike Watson, Vice President of OraNet, unpacks some of the most pressing challenges to clinical research in today’s climate.

Keeping clinical research on time and within budget despite COVID delays, staff shortages

Orbis International, an international nonprofit that aims to prevent and provide treatment for avoidable blindness, celebrates 40 years of innovation this year. Orbis began in 1982 with their iconic flying eye hospital, a fully accredited ophthalmic teaching hospital on board a plane. Since their start, Orbis has continued their innovation, working to achieve sustainable and scalable impact in the countries where they work.

Over the past four decades, Orbis has conducted tens of millions of eyes screenings and eye surgeries, as well as laser treatments for hundreds of thousands of patients. The organization has also trained hundreds of thousands of eye care professionals at all levels, including tens of thousands of medical doctors.

Orbis launched the flying eye hospital in 1982; in 1998, they launched their long-term country programs that are: training local eye care teams, building strong eye care systems, influencing national policies, and prioritizing eye care in Africa, Asia, the Caribbean and Latin America.

Through these efforts, Orbis has supported the establishment and improvement of:

800 primary eye care centers and health facilities

The coronavirus pandemic was a pivotal moment for Orbis. The organization implemented a door-to-door service delivery to ensure the eye care needs of their communities were met. 

In Ethiopia, Orbis successfully distributed millions of doses of antibiotics to fight trachoma, which is the leading cause of blindness to the people of Ethiopia. "Trachoma is highly contagious but is easily preventable and treatable with antibiotics if caught early," Macharia said. During the pandemic, Orbis took the mass drug administration of azithromycin door-to-door in Ethiopia, enabling the organization to reach over 12.3 million people in Ethiopia across 102 districts by the end of December 2021.

In Nepal, as schools were closed and children still needed eye screenings, with the help of an established government health workers group known as Nepal’s Female Community Health Volunteers (FCHVs), Orbis was able to ensure that children didn’t miss out on critical eye exams, as well as had the potential to reach children who live with disabilities, and who for other reasons may not be able to attend school.

“What we are really committed to doing is to ensure that we build health systems and support health systems, strengthening the countries where we work; ensuring that at the long-term capacities of local eye care professionals, doctors, ophthalmologists, optometrists, nurses, [and] community health care workers are enhanced,” Macharia said. “They will be the one to take ownership, they'll be the ones to lead, and they'll be the ones to ensure that we can expand even further than what we can.”

Looking ahead to the next 40 years, Macharia said that while she doesn't know exactly what it might look like, "I certainly know that we are going to cover even more."

"At the end of the day, it's just ensuring that we can be at the primary health care level," she said. "Really supporting communities and working closely and hand-in-hand with governments to support them and [to] deploy their operational plans, ensuring that they are meeting their targets and [achieving] impact." 

Orbis International celebrates 40 years of innovation this year, beginning in 1982 with their iconic flying eye hospital. Since their start, Orbis has continued their innovation, working to achieve sustainable and scalable impact in the countries where they work. Doris Macharia, MD, senior vice president of global programs with Orbis, talks with Ophthalmology Times' Sheryl Stevenson, reflecting on the last 40 years and what's to come.

Orbis' Doris Macharia, MD, reflects on where Orbis has been and the next 40 years to come

 This transcript has been lightly edited for clarity.

 And joining me today is Raj Kannan, the new CEO of Aerie pharmaceuticals. Thank you for joining us today.

Thank you, David, thank you for having me here.

We're coming off the heels of AGS in Nashville, and the return to live meetings is in full swing. How have things been going for Aerie at the meetings.

It's been wonderful. To see people in person, especially after a long hiatus that we've had, where we only saw people virtually. So just to meet people in-person, and to also get introduced to the world class clinicians and thought leaders for me, especially as a new CEO to Aerie was quite exhilarating, to say the least.

Can you update us on the latest developments in the Aerie pipeline?

Absolutely. Here's a company that I think is quite unique in the ophthalmic space; it has a commercial franchise [with] approved products with a novel MOA, that physicians are quite excited about. But more importantly, we have two Phase 3-ready assets, which is atypical for a small biotech company, our size — and I'll talk to you more about even our research program, our early-stage programs, we have a robust foundation in place to continue filling the pipeline with novel products. So, I'm excited about the pipeline, it becomes a question of capital, how much bandwidth you have in terms of funding all of these, how much risk appetite you have in terms of betting on these assets? Because not everything is going to get to market. And so how do you smartly think about partnering? How do you think about where do you want to focus? [These} are all the questions that we're currently focused on.

And what are some of the products that you kind of alluded to?

So obviously glaucoma, we've got a very good footprint right with two novel MOAs. And that's been about 20 years — the space has not seen any innovation in this particular space, and our products do something that no other product can do. So that by itself is quite a good place to be in glaucoma. We're equally excited about the two Phase 3-ready programs. And I'll talk to you about the two which [are] late stage. And that's more relevant for people than something that is still in early stage. So, we've got an asset that we term internally called AR-15512, which is a TRPM8 Agonist, which acts by stimulating the cold thermal receptors in your eye, and for producing tears in dry eye.

And so, what we see with this product in particular that we're excited about is the rapid onset of efficacy, which we don't see in the products that are currently in the market today. We saw almost a consistent pattern in how it reduced the symptoms that patients with dry eye suffer in our Phase 2b that we were quite excited about. And they were all trending in the same direction statistically significant, and in particular, on quality-of-life metrics.

So not only are we able to produce a robust amount of tear production in dry eye, but more importantly, we answer that question, “Well is how does the patient feel?” And we could say the patient feels better, right. And that's what we're aiming for in terms of a product profile. If we hit that product profile, we believe, David, that this could be a very compelling and differentiated product for patients that suffer with dry eye.

The other product, [about which] we're equally excited, which is we call AR-1105. And this has two things that I believe it validates. One is it validates our print technology platform, which is an extended dosing delivery mechanism that we have. So, the current standard of care in steroid in the space that we're competing in, is a product that is used once every two months. We've been able to take that, reduce the steroid dose by half, and extend the dosing delivery for once every six months. So, we think that is a meaningful differentiation for physicians and patients, especially in a condition like diabetic macular edema (DME) or retinal vein occlusion, and that is an asset that we are equally excited about.

And then what we did was we said internally, we could fund one of them; we can’t fund both. So, we are looking for partners to take that asset forward and bring it to market themselves.

And how's the glaucoma franchise performing for Aerie?

I would say the glaucoma franchise has done well. Certainly not done well versus external expectations, and that's the thing that I've always got to set. If you've got very high expectations, no matter what you do, or how well you do, you will always be sort of relatively contrasted with what you said.

I think when you look at a highly genericized marketplace, and look at the branded products, I think we have done reasonably well, given COVID-19, given the genericization in this particular marketplace, and given the payer pushback.

And I think what I'm more excited about is that we have a refreshed story of how to position the products really well for patients today than we had in the past. And the positive feedback that physicians are starting to get from their patients — and how well this product does — starts playing out over a period of time in terms of reinforcing that they should be prescribing this product for more of their patients. So, we continue to be optimistic and confident about the future of our glaucoma franchise, as well.

You kind of alluded to the pandemic, how much of an impact did it have on Aerie? And do you believe you're at the pre-pandemic levels regarding R&D and other operations?

So, I think Aerie was not unique in the sense of how we got affected. We certainly had products that were going through what I would call a “launch phase” during a pandemic. And no matter how much launch experience a pharmaceutical person has, I don't think any one of us had a playbook in how to go to market during a pandemic. So, this was something of a learning experience for all of us in terms of how to manage the customer engagement at a time when you couldn't see them in-person.

I think the other part that was important is even patients did not have access to the physician's office. So, one of the studies in 2020 that came out in ophthalmology said that 600,000 patient visits were missed compared to the previous year. Patients were not even going into the offices for their own care, because COVID-19 became sort of the priority of care.

Not just in ophthalmology, you could go across the board: diabetes, cancer, immunologic conditions, etc. patients who are struggling to get the kind of access and care during the pandemic. That is one piece that I feel is returning back to normal, in which patients are now increasingly getting back into the office, and we're seeing — rather than a flat market — the market growth for prescriptions is starting to inch back to the pre-COVID normal.

Two, I think in terms of access itself, we're starting to see an improvement in in-person meetings. And David, I was in a sales meeting, we had our entire sales force in-person that I never thought would be possible anymore. You know, it was great to have that. So that's getting back to normal, and the access to our sales force, our field force is starting to get back into 90% or more of these meetings in-person, which is very different than what we had in COVID.

The last piece is even in clinical trials, we become very savvy about making sure that if something like this happens in the midst of a clinical trial, that our statistical analysis plan — our missed data points —are all accounted for in the statistical analysis itself. So, there's a lot more focus on decentralizing clinical trials, there's a lot more focus on making sure if patients [can't] get to the site, how do you manage that? There’s been a lot of learnings and we've incorporated that as we think about clinical trials in the future.

The last piece is supply chain. Aerie’s very unique in that sense, that for a small biotech company, we established our own manufacturing plant. So really getting that supply chain in-house and mitigating the risks to the extent we can, is an important piece that we as an industry learned during COVID-19, as well.

What is one thing that you would like ophthalmologists to know about the work going on at Aerie?

If there's one thing I would like them to know it's that we're a small company; we're not a big behemoth, and we're quite innovative. And usually, the conventional wisdom will tell you that smaller companies tend to be more agile, nimble and innovative than large behemoths. And it was very heartwarming for me to hear that from the thought leaders and clinicians at AGS, because they were saying they were rooting for our success, because we were one of those small companies that they did not want us to lose as a piece of a massive behemoth, where innovation starts struggling. And it is true, 70 to 75% of all innovations today in pharmaceuticals comes from small biotech companies and physicians and prescribers and thought leaders do recognize that.

What is your outlook for the rest of 2022, and maybe into 2023?

I would say this is Aerie version 2.0, as we dub internally; always trying to get to be a better version of yourself and the company and in Aerie version 2.0 we're going to be a lot more focused in knowing what we're great at doing. And then partnering and giving to somebody else who's better at it than trying to do it all by ourselves.

So, you'll see Aerie version 2.0 becoming very focused in what we want to do and where we want to play and how do we want to leverage our strengths.

Excellent. Thank you so much for your time today; we really appreciate it. And as we get back to live meetings here, I'll make sure to keep my eyes out and hopefully we'll cross paths and I get to say hello in-person.

Thank you, David. I look forward to meeting in-person, as well. And thank you for having me; I really appreciate it.

Raj Kannan, the new CEO of Aerie Pharmaceuticals, talks with Ophthalmology Times' David Hutton about what's coming down the pipeline for Aerie.

Aerie Pharmaceuticals CEO discusses what's new in the pipeline

Sotrovimab (GlaxoSmithKline), a monoclonal antibody, appears to reduce the risk of progression of mild-to-moderate cases of COVID-19 in patients at high risk of progression according to Anil Gupta, MD, from the Albion Finch Medical Centre, William Osler Health Centre, Toronto.

 on behalf of the COVID-19 Monoclonal Antibody Efficacy Trial–Intent to Care Early (COMET-ICE) investigators.

In this ongoing, multicenter, double-blind, phase 3 trial, outpatients with COVID-19 symptoms for 5 days or less who were at high risk for disease progression were randomized to 1 sotrovimab infusion (dose, 500 mg) or placebo. 

The primary study outcome was hospitalization for more than 24 hours for any cause or death within 29 days after random assignment.


The interim analysis included 583 patients; 291 were randomized to treatment with sotrovimab and 292 to placebo.

Analysis of the primary outcome showed that COVID-19 progressed in 3 patients treated with sotrovimab compared with 21 patients treated with placebo (1% compared with 7%, respectively; p=0.002) leading to hospitalization or death.

The safety analysis included 868 patients, ie, 430 randomized to sotrovimab and 438 to placebo; 17% and 19%, respectively, reported adverse events; serious adverse events occurred less frequently with sotrovimab (2%) compared with placebo (6%), the investigators reported.

Based on these results, Gupta and colleagues concluded that in this high-risk population of patients with mild-to-moderate cases of COVID-19, sotrovimab reduced the risk of disease progression and no safety signals were identified.

“The results of this interim analysis of COMET-ICE indicate that sotrovimab can be a therapeutic agent for outpatients with COVID-19,” the investigators wrote. “Notably, a 500-mg dose may also permit intramuscular administration, which may increase the convenience of and access to therapeutic antibody agents for patients with COVID-19. Studies are currently under way to evaluate this route of administration.”

Sotrovimab, a monoclonal antibody, appears to reduce the risk of progression of mild-to-moderate cases of COVID-19 in patients at high risk of progression. 

COVID-19

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